Can a personalized home program slow memory decline?

NCT ID NCT05375513

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers are testing whether a personalized home-based program can help prevent dementia in older adults with mild cognitive impairment. The program combines physical activity, cognitive training, diet, sleep, and management of vascular risk factors, all tailored to each participant and delivered remotely with bi-weekly coaching. The trial aims to see if this approach improves global cognition and brain health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
A personalized home-based program combining physical activity, cognitive training, diet, sleep, and vascular risk factor management, delivered remotely with bi-weekly coaching
What this could lead to
If it works, this could offer a scalable way to slow memory decline and delay dementia in older adults with mild cognitive impairment, potentially reducing healthcare costs.
What could go wrong
The trial is relatively small and early, so it may not show a clear benefit. Participants must stick to a demanding program, and remote delivery may not suit everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2023

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 to 85 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria 1. Ages 60-85 years. 2. Having mild cognitive impairment (MCI) defined as meeting all of the following: 1. Presence of subjective memory complaints from the participant and/or informant. 2. Objective impairment on cognitive tests independent of outcome measures.† 3. Preserved activities of daily living assessed (\>14/23 in Lawton-Brody IADL score). For the study, impairment of daily living will be assessed based on cognitive abilities, not physical abilities. 4. Absence of clinical dementia per DSM-IV criteria †Objective cognitive impairment is operationalized as: Montreal Cognitive Assessment (MoCA) total score between 16 and 25 (inclusive), and/or RAVLT delayed recall ≤6, and /or Clinical Dementia Rating Scale (CDR) =0.5 3. Have at least 1 dementia risk factors targeted by our intervention as follows: low physical activity (less than 150 minutes of moderate-to-vigorous-intensity physical activity per week, as per GAQ), poor diet (14-item Mediterranean Diet Assessment (MDA-14) score ≤7), insomnia or subthreshold insomnia ( Insomnia Severity Index (ISI) score \>7), and vascular-metabolic risk (Cardiovascular Risk Factors Aging and Incidence of Dementia (CAIDE) score ≥6 and/or diabetes (type I or II) and/or obesity (BMI≥30) and/or diagnosis of high blood pressure (hypertension) and/or smoking). 4. Have access to a home computer/laptop/tablet with home internet (have regular access to email) and ability to use technology (able to send and receive emails and join video conferences). 5. Self-reported levels of proficiency in English for speaking and understanding spoken and written language. 6. Have normal/corrected to normal vision in at least one eye to identify stimuli on computer/tablet screen. 7. Have normal to corrected hearing ability, in order for the participant to engage in digital/virtual communication. Research personnel will determine and assess the hearing ability as per participant's performance. 8. Able to comply with virtual visits, treatment plan, and trial-related activities. 9. Ability to participate in the study's exercise training as determined by the Get Active Questionnaire (GAQ). Exclusion Criteria 1. Having a diagnosis of dementia (based on DSM-IV criteria). 2. Underlying severe disease that precludes engagement with interventions, including presence of psychiatric diagnoses (i.e., major depression (Geriatric Depression Scale (GDS-30) \>19), schizophrenia, severe anxiety, neurological disorder with severe motor deficits, such as current parkinsonism or any neurological disorder with residual severe motor deficits (i.e., stroke with motor deficit), or presence of unstable (non-controlled e.g., symptoms that suggest instability or no treatment for their condition) chronic disease such as congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD) that may preclude the participant from engaging properly with the trial interventions, or advanced-stage active cancer that at the study physician's discretion will prevent them from participating. 3. Having had surgery within the last 2 months or having an upcoming planned surgery in the next 12 months that could interfere with the participant's vision, hearing, mobility, or any other abilities to participate in the study. 4. Regular use of Benzodiazepine or neuroleptic drugs that may interfere with the participants ability to participate in the assessments and interventions. 5. Recent (in the past 12 months) and/or current substance or alcohol abuse. 6. Having had a transmural myocardial infarction (severe heart attack) within six months prior to enrollment in the clinical trial that according to the study physician may preclude physical activity performance. 7. Intention to enroll in other interventional clinical trials during same time.

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Conditions

The condition(s) this trial relates to.

Cognitive Dysfunction dementia prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Baycrest Academy for Research and Education

    RECRUITING

    Toronto, Ontario, Canada

  • Concordia University

    RECRUITING

    Montreal, Quebec, Canada

  • St. Joseph's Health Care London, Parkwood Hospital

    RECRUITING

    London, Ontario, N6C5J1, Canada

  • University of Alberta

    RECRUITING

    Edmonton, Alberta, T6G 2G3, Canada

  • University of British Columbia

    RECRUITING

    Vancouver, British Columbia, Canada

  • University of New Brunswick

    RECRUITING

    Fredericton, New Brunswick, Canada

  • University of Ottawa

    RECRUITING

    Ottawa, Ontario, Canada

  • University of Waterloo

    RECRUITING

    Waterloo, Ontario, Canada

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